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Monoclonal Antibodies

Combination Therapy for Multiple Myeloma

Phase 1 & 2
Waitlist Available
Led By Ashraf Badros, MB; ChB
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prior treatment-related toxicities must be ≤ Grade 1 except peripheral neuropathy (Grade-2)
Histologically confirmed diagnosis of Refractory MM; failed at least 3 prior lines of anti-myeloma treatments, including an anti-CD38 antibody and is refractory to an IMiD and to a proteasome inhibitor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization until the date of death from any cause, assessed up to 100 months
Awards & highlights

Study Summary

This trial is testing a new combination drug treatment for multiple myeloma, a cancer of the blood.

Who is the study for?
This trial is for adults with Multiple Myeloma that's come back or hasn't responded to treatment. They must have tried at least three prior treatments, including specific anti-myeloma drugs, and not had certain stem cell transplants recently. Participants need good organ function, no active infections, and can't be pregnant or breastfeeding.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of combining Belantamab Mafodotin with Cyclophosphamide and Dexamethasone in patients whose Multiple Myeloma has relapsed or is refractory. It aims to see how well this combination works as a treatment option.See study design
What are the potential side effects?
Potential side effects include eye problems like blurry vision, blood disorders such as low platelet counts, infusion reactions from the drug entering the body, fatigue, nausea, fever, respiratory infections and potential liver issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My side effects from previous treatments are mild, except for possible moderate nerve pain.
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I have multiple myeloma and previous treatments, including specific antibodies and inhibitors, didn't work.
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I am 18 years old or older.
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I can take care of myself and am up and about more than half of the day.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization until the date of death from any cause, assessed up to 100 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization until the date of death from any cause, assessed up to 100 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall incidence and severity of AEs in Dose Escalation
Response rate in Expansion Cohort
Secondary outcome measures
Cytokine Profile Data
Overall survival
Progression free survival
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm BExperimental Treatment1 Intervention
Dose level 1: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 6 weeks cycles. Dose level 2: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 each 6 weeks cycles.
Group II: Arm AExperimental Treatment1 Intervention
Dose level 1: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 3 weeks cycles. Dose level 2: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 each 3 weeks cycles.

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
692 Previous Clinical Trials
376,854 Total Patients Enrolled
10 Trials studying Multiple Myeloma
114 Patients Enrolled for Multiple Myeloma
Ashraf Badros, MB; ChBPrincipal InvestigatorUniversity of Maryland, Baltimore

Media Library

Belantamab Mafodotin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04896658 — Phase 1 & 2
Multiple Myeloma Research Study Groups: Arm A, Arm B
Multiple Myeloma Clinical Trial 2023: Belantamab Mafodotin Highlights & Side Effects. Trial Name: NCT04896658 — Phase 1 & 2
Belantamab Mafodotin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04896658 — Phase 1 & 2
~3 spots leftby Jun 2025
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